TransEnterix files FDA 510(k) application for Senhance, prices $24.9m round

TransEnterix (NYSE:TRXC) said today it filed an application with the FDA seeking 510(k) clearance for its Senhance robotic surgery platform, and that it priced an upcoming $24.9 million round to support the company and device through the process.

The application is a huge step forward for the company, according to CEO Todd Pope, who spoke to MassDevice.com in an interview today.

“The most important milestone that we’ve hit now is that we have filed our FDA 510(k) submission with the FDA, and we wanted to make sure we have enough cash to get all the way through submission, acceptance, and a launch here in the US,” Pope said in an interview with MassDevice.com

Pope said that he’s hopeful the company’s application will be approved within 6 months, though he offered that the timeframe relies on some back-and-forth with the FDA and could be shorter or longer.

“It’s great that we’ve filed with the FDA, and it’s great that we now have cash to fund our operations well beyond the response back from the FDA and our launch here in the US,” Pope said.

The system has also seen some significant upgrades in the past few months, Pope said, as the company added compatibility with both Stryker (NYSE:SYK) and Novadaq vision systems.

“We are now compatible with 2 of the leading vision systems on the market today – Stryker and the Novadaq systems. Both of those are now compatible with our Senhance robot, and that’s a big move forward for the industry. Instead of a closed system, it’s more open architecture to allow hospitals and surgeons to use those vision systems in conjunction with the Senhance,” Pope said.

Pope said the entry was exciting for the company – and for medtech industry in the US, which hasn’t seen another robotic system cleared for the Senhance’s applications in almost 20 years.

“There hasn’t been another robot in the US market since the late 1990s for the applications, so the market is very excited. In Medtech you won’t find another category that hasn’t had a second entrance in 18 years, so that’s exciting, we feel close now and I think that’ll be a great thing for the market,” Pope said.

In the funding round TransEnterix will offer units consisting of 1 share of common stock, 1 Series A warrant to purchase antoher share of common stock and 1 Series B warrant to purchase 0.75 shares of common stock at a price of $1 per unit.

Series A warrants in the round will be exercisable at any time after issuance and usable up to 1 year, with the caveat that the units will expire within 10 days if the company receives FDA 510(k) clearance. Series B warrants in the round will be exercisable from the date of issuance through 5-years, the company said.

“So, the Series A will allow us, within those 10 days of FDA approval, to raise upwards of another $24.9 million,” Pope added.

Pope said he would be speaking more on future developments for the system and the company’s success with it in the European Union during the company’s earnings report release, scheduled for May 10.

Stifel is acting as the sole book-running manager for the offering, which is slated to close on or about May 3, according to a press release.

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